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Director, Quality Assurance

Director, Quality Assurance

Job Description

Position Title: Director, Quality Assurance
Department: Quality
Reports to: SVP R&D (or CEO)
Date: 2018

Summary:

The Director of Quality will be responsible for development, implementation and continuous improvement of comprehensive Quality Systems and Quality Assurance (QA) and Quality Control (QC) functions to ensure that all Company research, development and manufacturing activities are conducted in compliance with applicable GxP requirements. The successful candidate will have a thorough knowledge of GCP regulations as well as experience with oversight of global biologics manufacturing cGMP regulations. GLP knowledge preferred but not required.

Responsibilities:

  • Develop and execute short- and long-term Quality plans in alignment with overall Company strategy, ensuring clinical trials conducted in compliance with GCPs.
  • Oversee development and updating of Quality Manual, policies, and SOPs
  • Develop and manage quality training initiatives and document control systems
  • Planning and leading audit activities at clinical site audits, sponsor audits, key document audits and system validation audits
  • Participating in developing, maintaining and improving the Pharmaceutical Quality System within the GCP area
  • Providing QA expertise to the organization and quality oversight of drug safety and pharmacovigilance functions
  • Proactively assisting the organization in preparation, coordination, hosting, conducting, documentation and follow up for regulatory inspections
  • Providing advice internally and externally on GCP, pharmacovigilance and clinical quality matters
  • Reviewing and evaluating the quality of contract partners (i.e., CROs)
  • Manage documentation, reporting, and closure of GxP compliance matters
  • Provide guidance, interpretation, support, training, and input on the interpretation and implementation of regulations, guidelines, and Company procedures
  • As a member of management, advise the Company on external developments (e.g., new regulations, enforcement) and strategic compliance trends

Requirements:

  • Bachelor’s or MS degree in a scientific or technical discipline required; PhD strongly preferred
  • 8 years of relevant QA experience within the pharmaceutical industry, including hands on experience in the pharmacovigilance area, conducting clinical trials, oversight of pharmacovigilance area and practical experience in regulatory inspection preparation and conduct; Experienced Auditors within the GCP area preferred
  • Strong understanding of Quality processes with flair for the practical angle to creatively reach a compliant solution
  • Collaborative and strategic minded
  • Customer focused and able to deal with ambiguity
  • Exceptional verbal and written communication skills
  • Proficiency in Word, Excel, and PowerPoint
  • Ability to prioritize, maintain a positive attitude and thrive in a fast paced and changing environment
  • Ability to travel
  • High attention to detail and demonstrated ability to work well under pressure and through adversity